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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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4 February 2013 |
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Main ID: |
NCT00189436 |
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Date of registration:
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12/09/2005 |
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Primary sponsor: |
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Public title:
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Effect of Nebulized Budesonide and Oral Corticosteroids on Wheezing Episode Relapse in Children
BudER |
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Scientific title:
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A Pilot Study to Evaluate the Effect of Nebulized Budesonide and Oral Corticosteroids on Wheezing Episode Relapse in Pediatric Patients Following Discharge From the Emergency Department/Outpatient Care Facility |
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Date of first enrolment:
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March 2003 |
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Target sample size:
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61 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00189436 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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Countries of recruitment
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United States
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Contacts
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Name:
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David Skoner, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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West Penn Allegheny Health System |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Children ages 1-8 years old
- Discharge from emergency department/outpatient clinic with a diagnosis of asthma
exacerbation after usual standard care
- Subjects must be able to show efficient use with a jet nebulizer
Exclusion Criteria:
- Subjects requiring hospitalization
- Subjects receiving oral steroids 1 week prior to presentation to emergency
department.
- Subjects with FEV1 < 50% of predicted
- Subjects with co-morbid medical conditions (renal or cardiovascular disease)
- Subjects with reported history of HIV
- Subjects unable to follow up for study visits
- Subjects who are frequently enuretic
Age minimum:
1 Year
Age maximum:
8 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Asthma
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Intervention(s)
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Drug: Nebulized Budesonide
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Drug: Usual care (albuterol with or without oral steroid)
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Primary Outcome(s)
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Wheezing/Asthma/Bronchospasm relapse rate
[Time Frame: 3 weeks]
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Secondary Outcome(s)
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Spirometry readings
[Time Frame: 3 weeks]
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Urinary Cortisol
[Time Frame: 3 weeks]
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Secondary ID(s)
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BUD ER 3425
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RC - 3425
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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